The U.S. Food and Drug Administration (FDA) has approved the first surgically implanted prosthetic iris (the colored part of the eye around the pupil) for adults and children whose iris is partially or fully missing or damaged due to injury, surgery (for melanoma, for example), or a rare congenital condition called aniridia.
The iris controls the amount of light that enters the eye, and when the iris is missing or damaged, sensitivity to light and severe vision problems occur. According to the FDA, the new artificial iris, called the CustomFlex Artificial Iris, reduces sensitivity to bright light and glare and improves the cosmetic appearance of the eye.
The artificial iris is made of thin, medical-grade silicone and is custom-sized and colored for each patient. It is implanted via a small incision and held in place by the anatomical structures of the eye or with sutures, if needed. In clinical trials, more than 70 percent of 389 adult and child patients reported significant decreases in light sensitivity and an improved health-related quality of life following implantation, and 94 percent were satisfied with the appearance of the artificial iris.